At a glance
ClinicalIndex Comparison Record- ✓Biopsy-proven unresectable adenocarcinoma of the pancreas
- ✓Unresectable, borderline resectable, medically inoperable pancreatic carcinoma, or refusing surgery
- ✓Biliary obstruction allowed if drainage tube placed before treatment
- ✓Willing to use contraception during treatment and for 12+ months after
- ✕Evidence of distant metastasis
- ✕Prior surgical resection
- ✕Previous invasive malignancy within 5 years (except non-melanoma skin cancer and low-intermediate risk prostate cancer)
- ✕Active or untreated infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Escalated Dose Proton Radiotherapy With Elective Nodal Irradiation and Concomitant Chemotherapy for Patients With Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating Proton Radiation, Capecitabine, and 1 other intervention for Pancreatic Cancer. Currently recruiting, targeting 60 participants across 4 sites.
Detailed Summary
The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
Study Details
Timeline
Interventions
Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.